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FDA Clears Procalcitonin Assay for Sepsis Patients

Test detects sepsis-specific biomarker

The FDA has granted 510(k) clearance for the Elecsys Brahms PCT (procalcitonin) assay (Roche) for patients with severe sepsis or septic shock. PCT is a sepsis-specific biomarker associated with bacterial infection. The new assay can aid in assessing the risk of critically ill patients to progress from severe sepsis to septic shock and can help determine the 28-day mortality risk in sepsis patients.

The Elecsys Brahms PCT assay is designed to provide full automation, which means that no reagent preparation or hands-on testing is required. The assay offers same-day testing capability with an incubation time of 18 minutes, according to Roche. It also has a broad measuring range (0.02 ng/mL to 100 ng/mL, extending to 400 ng/mL with a recommended 1:4 dilution).

Sepsis contributes to more than 1.6 million hospitalizations annually in the United States and is the most common cause of death in intensive care units. Sepsis is a potentially life-threatening complication that can arise when the body develops a severe inflammatory response to an infection. If unchecked, sepsis can rapidly progress, leading to organ dysfunction, and if not managed properly, it may cause death. Clinical manifestations of sepsis can be vague, and the infection may progress undetected by signs and symptoms to a severe condition.

While any individual with a severe infection has the potential to develop sepsis, the very young, the elderly, and the immunocompromised are particularly vulnerable. Early diagnosis and management of sepsis, usually with antibiotics and large amounts of intravenous fluids, improves patients’ chances for survival.